MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Model Number SGC0301

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other device mentioned will be filed under a separate medwatch report.

Event Description

This is being filed to report the torn tip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was successfully implanted.A second clip delivery system (cds) was advanced to the mitral valve however the mr was unable to be reduced further.The leaflets were ungrasped and the clip repositioned several times however the mr was unable to be reduced.The cds was retracted per the instructions for use (ifu) however the clip became caught on the tip of the steerable guide catheter (sgc).Standard troubleshooting was performed; however the clip could still not be retracted.The system was pulled back to the right side and pulled through the septum without issue.It was noted the clip looked like it had detached from the mandrel even though no deployment had been initiated.The sgc and cds were retracted to the groin where it was noted one clip arm was inside the sgc and one clip arm was stuck on the vessel wall.A vascular surgeon was called to perform a cut down.Once removed, it was confirmed the clip was no longer attached to the mandrel but was still attached to the cds by the lock and gripper lines.The procedure was completed at this time with the mr reduced to 3.There was no clinically significant delay in the procedure and no adverse patient sequela.Return analysis noted the tip of the sgc was torn.No additional information was provided.

Manufacturer Narrative

The returned device analysis observed a damaged soft tip and the shaft was bent.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation determined the damaged soft tip appears to be related to procedural conditions and the bent shaft was likely due to post procedure shipping and handling.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9921295
• MDR Text Key: 186367400
• Report Number: 2024168-2020-03337
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 91122U130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Age: 82 YR
• Patient Weight: 100